MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-06 for ASPIREASSIST A-TUBE NOT APPLICABLE 100-0011 manufactured by Aspire Bariatrics, Inc.
[182704441]
Initial report indicated that the skin port had separated from the a-tube. Subsequent email described the a-tube as separated at the bumper. There is no information to suggest that the a-tube which had been implanted for 20 months had any signs of material degradation. The skin port attachment to the a-tube and the a-tube overmold are both designed and tested to ensure that normal forces which might be applied to the device do not result in separation with an appropriate safety margin. Without having the device to evaluate, it is not possible to determine the root cause of this event. The patient underwent endoscopy to remove the device from the stomach. There were no issues with removal of the tube and the procedure was well tolerated.
Patient Sequence No: 1, Text Type: N, H10
[182704442]
Patient is (b)(6) female with a history of obesity undergoing aspire assist therapy, a-tube placement in (b)(6) of 2018. Rn reported being contacted by a patient who stated that the skin port had come off and the a-tube had retracted into the stomach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009595931-2020-00001 |
| MDR Report Key | 9554017 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-07 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2015-09-15 |
| Date Added to Maude | 2020-01-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MONICA FERRANTE |
| Manufacturer Street | 319 N POTTSTOWN PIKE SUITE 202 |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4842001031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIREASSIST A-TUBE |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | OYF |
| Date Received | 2020-01-06 |
| Model Number | NOT APPLICABLE |
| Catalog Number | 100-0011 |
| Lot Number | F100913 |
| Device Expiration Date | 2018-09-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPIRE BARIATRICS, INC |
| Manufacturer Address | 319 N POTTSTOWN PIKE SUITE 202 EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-06 |